An interventional study of techniques of ultrasound examination of the airway in Critical Illness, Difficult; Intubation, Postpartum, During Puerperium and Pre-Eclampsia, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Ain Shams University · Not applicable, Interventional, and Diagnostic
Among 79 studies in Pre-Eclampsia with a site in Egypt — 11 open to participants now, 12 under way, none of them phase 3. Pre-Eclampsia · Egypt.
Among the 79 studies in Pre-Eclampsia with a site in Egypt, this one is the 35th largest by planned enrollment of the 40 interventional ones that give a count, is one of 10 that started in 2024, is one of 21 with no phase, reaches primary completion later than 5 of the 11 other live ones, and was the 66th registered.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
Browse Pre-Eclampsia studies →11 of the 79 studies in Pre-Eclampsia with a site in Egypt are open now. Recruiting first, the newest first:
Cairo University · Sites in Egypt
Ages 20–40 · Women only
Tanta University · Sites in Egypt
Ages 18–40 · Women only · Healthy volunteers
South Valley University · Sites in Egypt
Ages 18–50 · Women only · Healthy volunteers
Ain Shams Maternity Hospital · Sites in Egypt
Ages 18+ · Women only
Ain Shams University · Sites in Egypt
Women only
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: female · no healthy volunteers.
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79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 6 · Phase 4 9
First in 2013; this study’s year is marked. 10 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Median enrollment 100 across the 40 interventional studies, 90 across the 39 observational. Of the 39 that completed or were terminated, 0 (0%) have results posted.
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1 of 79 have an industry lead sponsor. The 10 most frequent:
Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ain Shams University has 8 studies filed under Pre-Eclampsia — fewer than ten, so there is no comparison to draw.
2 of the studies in Pre-Eclampsia with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07423741South Valley UniversityUltrasonographical Assessment of Airway Indices in Pregnancy | 2026-11 |
| NCT07443345Cairo UniversityIncidence of Postoperative Diaphragmatic Dysfunction in Pregnant Women With Preeclampsia | 2026-12-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 79 studies in Pre-Eclampsia with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Unexpected difficult airway exposes the patient to serious morbidity and even mortality. The changes in pregnancy and preeclampsia increase the risk of difficult intubation. Proper anticipation affects the outcome and enhances safety, especially in critically ill patients. This research aims to assess the superiority of either 2 views or 5 views ultrasound assessment in predictivity of difficult airway (difficult ventilation, laryngoscopy, and intubation) and their comparison to traditional clinical examination by El-Ganzouri Risk Index (EGRI) in critically ill obstetric patients with pre-eclampsia.
Unexpected difficult airway exposes the patient to serious morbidity and even mortality. Obstetrics airway carries the risk of complications due to physiological changes. The airway shows more restriction and changes in preeclamptic patients and peripartum periods. A study reported one incidence of difficult intubation in obstetrics in 20 cases. Inadequate airway management leads to failure in ventilation and oxygenation of the critically ill mother and her fetus.
the Practice Guidelines for Management of the Difficult Airway by the American Society of Anesthesiologists (ASA) define the difficult airway as difficult facemask ventilation of the upper airway, difficult tracheal intubation, or both. preoperative assessment of the airway avoids that risk; however, current clinical screening tests have low sensitivity and specificity with limited predictivity.
Ultrasound (US) provides a more precise assessment for tissues like epiglottis, vocal cords, and ring-shaped membranes; thus, it facilitates a bedside, non-invasive objective airway assessment. Moreover, ultrasound assessment can plan and guide airway interventions if needed. The airway in pregnancy goes through changes. a study concluded that The US airway assessment parameters differ significantly between pregnant and non-pregnant patients. Previous studies reported that the best predictors of difficult laryngoscopy and/or difficult intubation were the epiglottis midline-skin distance, hyoid bone-to-skin distance, thyroid cartilage-to-skin distance, thyrohyoid membrane-to-skin distance, and vocal cord anterior commissure-skin distance also predicted difficult airway. In Pregnancy, hyoid bone visibility, and Pre-E/E-VC ratio were independent predictors of the difficult airway.
Researchers suggested different techniques for airway ultrasound. Some suggested detailed technique that allows the determination of multiple parameters. Others suggested a more concise protocol to lessen the time of assessment and to avoid complexity.
This trial assesses the superiority of either 2 views or 5 views ultrasound assessment in predictivity of difficult airway (difficult ventilation, laryngoscopy, and intubation) and their comparison to traditional clinical examination by El-Ganzouri index (GREI) (9) in critically ill obstetric patients with pre-eclampsia.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 50 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Pre-Eclampsia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria:Critically ill preeclamptic patients for caesarean section under general anesthesia with the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
: the ultrasound examiner will use the difficult airway examination by sonography (DARES) protocol in which involves only two views of the upper airway: the thyrohyoid and the suprahyoid views. Measurements selected for this protocol include the DSE, HMD, HMDR1, HMDR2, and tongue thickness, which cover all three domains of TTD, APD, and OSD
Diagnostic Test: techniques of ultrasound examination of the airway
The thicknesses of the anterior neck soft tissues will be measured by systematic examination includes five views: 1) Suprahyoid View .2) Thyrohyoid view; will be used to visualize epiglottis and pre -epiglottic space(PES).3) Thyroid view; for vocal cord visualization.4) Cricothyroid view .5) Suprasternal view From the previous views the following will be measured: tongue volume (TV ) ANS-H: anterior neck skin thickness at hyoid; TMD: thyromental distance; ANS-E: anterior neck skin thickness at epiglottis; ANS-VC: anterior neck skin thickness at vocal cords; SD: subglottic diameter PreE: pre epiglottic space; aVF: anterior vocal folds; pVF: posterior vocal folds; mVF: midpoint of anterior , posterior vocal folds , and diameter of the transverse tracheal air shadow in the subglottic area . The following will be calculated PreE/aVF, PreE/mVF , PreE/pVF and PreE/E-VC. That will be in addition to detection of any abnormalities in the airway
Diagnostic Test: techniques of ultrasound examination of the airway
two different techniques of ultrasound. The techniques are the two views and the five views
The predictivity of both us techniques in relation to clinical assessment of El-Ganzouri index (EGRI).
Sensitivity and specificity of the measured parameters in both ultrasound techniques in relation to the clinical El-ganzouri score where (score \< 4 is unlikely to be difficult and score ≥ 4 is more likely to be difficult) to predict difficult airway.
Time frame: the degree of difficult intubation will be assesed intraoperative after aneesthesia and intubation, clinical assessment will be preoperative, the us assessment will be preoperative at the same day of operation or immediately postoperative
The predictive superiority between 2 view and 5 views ultrasound techniques regarding difficult ventilation, laryngoscopy and intubation
* Difficult ventilation is measured by Hans score where grade 0 and 1 will be categorized as easy ventilation, while \<= 2 are difficult * Difficult intubation is measured by Cormack-Lehane grade where where grade 1 nad 2a will be categorized as easy while \<= 2b will be categorized as difficult. * Prolonged intubation \<10 min or repeated attempts \< 3 will be categorized as difficult.
Time frame: the actual degree of difficult intubation will be assesed intraoperative after aneesthesia and intubation, the us assessment will be done preoperative at the same day of operation or immediately postoperative
postoperative side effects
Any postoperative adverse effects as patient discomfort from airway, mandibular pain or stridor
Time frame: within 24 hours postoperative
duration of the airway assessment
time needed for ultrasound evaluation measured from the start of the technique till the end of the ultrasound examination, and duration of the clinical EL-Ganzouri assessment
Time frame: preoperative
Plan to share: Undecided
Started Jul 2024 (actual). Primary completion is estimated for Nov 2025, 16 months after the start.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 16 months is below that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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